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SCADPlus: Marketing authorisation for medicinal products for human use: additional conditions relating to testing
To adopt a new procedure to introduce technical updates into the legislation on the testing of medicinal products so as to make it more effective. ... Article 4 of Directive 65/65/EEC ... the Community marketing authorisation procedures for medicinal products [Official Journal C 229 ...
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SCADPlus: Marketing authorisation for medicinal products for human use: additional conditions
To pursue the approximation begun by Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products with a ... medicinal products: Official Journal C 163, 30 ... decisions on marketing authorisation pursuant to Article 12 or Article ...
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L 159/46 EN 27.6.2003 Official Journal of the European Union COMMISSION DIRECTIVE 2003/63/EC of 25 June 2003
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... EN27.6.2003Official Journal of the European Union ... on the Communitycode relating to medicinal products for ... the application for Marketing. Authorisation pursuant to Article 8 (3) (d ...
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Official Journal of the European Communities 10.6.2000 L 139/28 COMMISSION DIRECTIVE 2000/38/EC of 5 June 2000
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as last amended by Directive 93/39/EEC (2), and in particular Article 29i thereof,Whereas:( ... regulation or administrative action relating to medicinal products ... text: Article 29d1.The marketing authorisation holder shall ...
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Academy of Legal Studies in Business Section of Marketing
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4 Gadgets to Stay Connected on the Road (Deal of the Day)

As Americans look to save on travel costs and gasoline prices hold fairly steady, more people are turning to their own cars to get them where they want to go. But few sounds drown out the joy of a summer road trip faster than a backseat chorus of “Are we there yet?”

Fortunately for the chauffeurs of the vocal and impatient, gadget makers have released new devices designed to make car trips easier for passengers, not to mention drivers. Among the possibilities: tuning into live TV while idling in traffic, getting enough battery power from your computer to play the entire "Harry Potter" DVD lineup back-to-back, and turning your cellphone into a radar detector.

SmartMoney.com talked to auto and electronics experts, as well as drivers, to find car-worthy gadgets. Here are four ways to stay in touch on the road:

1) Live TV

New satellite services ensure that a lengthy road trip doesn’t mean the family misses the latest episodes of hit summer series like “Burn Notice,” or popular kids’ shows, such as “Hannah Montana.” “This would be a lifesaver,” says Lisa Tyler, a spokeswoman for social networking site MomsLikeMe.com. She routinely sets up the car’s DVD player with videos for her four-and-a-half year-old twin boys but says it’s tough to keep their interest with the same shows on the family’s annual 14-hour summer roadtrip from Virginia to Florida. “With TV, you get the variety of programming,” Tyler says.

Systems can be installed in most vehicles, as long as you have an FM radio and a monitor. The technology is still in early adoption, so expect to pay steep fees for equipment. A few systems on the market:

  • AT&T (T) CruiseCast. Browse the lineup of 42 satellite TV and radio channels, including Disney (DIS) XD, Discovery Kids, Animal Planet and Accuweather. The antenna/receiver combo costs ,300, and a monthly subscription is .
  • DirecTV (DTV) Total Choice Mobile. Watch any of the satellite service’s 185 channels, including the major networks and niche offerings like The History Channel and Spike. The service requires a subscription to the satellite provider (packages start at per month) and an unobtrusive receiver (roughly ,000) to be installed on your vehicle’s roof.
  • Sirius (SIRI) Backseat TV. Programming is currently limited to three kid-friendly channels: Nickelodeon, Disney Channel and Cartoon Network. To set up the service you’ll need an audio/video tuner (0), as well as a monthly subscription (, in addition to regular satellite radio subscription fees, which start at a month).

2) Power converter

Forgot the car charger for your favorite electronic device? No sweat. Inexpensive power converters enable you to power any device that uses a standard plug, including your cellphone, your laptop or a blender for smoothies near the beach. This coffee-cup-shaped version (, from ThinkGeek) plugs into the cigarette lighter in your vehicle. It can power up to three devices at the same time, and fits into the car’s drink holder for easy storage and access.

3) Your smartphone

Whether he’s driving the family car or his motorcycle, debt counselor Steve Rhode of GetOutofDebt.org always brings his Apple (AAPL) iPhone along for the trip. “It’s my travel essential,” he says. “I rely on it.” In addition to music and games, Rhode has loaded his phone with apps to make his trips easier, including weather monitor RadarScope (.99 on iTunes) and “AroundMe” (free), which locates the nearest restaurants and other amenities. “I can make a more informed decision about where I get off the highway,” Rhode says. A few other useful apps for the road:

  • Trapster. Avoid speeding tickets with this free app for the BlackBerry, iPhone, Android device or other phone operating system. It uses GPS to alert you when you’re approaching known speed traps, red-light cameras and speed cameras.
  • SitorSquat. This free app for BlackBerry and the iPhone uses GPS to find nearby restrooms. An active user community rates each from zero to five stars for cleanliness.

4) GPS

New standalone and dashboard models on the market do more than direct you from Point A to Point B. Some alert you to congested roadways and offer alternate routes to cut your travel time. Voice activation commands let you keep your eyes on the road and your hands on the wheel. A handful — like the Garmin (GRMN) nüvi 265WT (on sale at Best Buy for 0, a 33% discount) — include Bluetooth technology, which allows you to reroute cellphone calls through the device’s built-in speakers and microphone. “We’re all in favor of anything that prevents distraction in a vehicle,” says Fran Clader, a spokeswoman for the California Highway Patrol, which has issued more than 100,000 citations to drivers using handheld cellphones on the road. And in New Jersey, hands-free might soon be the only legal way to operate your GPS.)

Many GPS models also include programs that can play your MP3 collection, point you to the nearest bookstore or amusement park and locate the cheapest gas around.

SMARTMONEY ® Layout and look and feel of SmartMoney.com are trademarks of SmartMoney, a joint venture between Dow Jones & Company, Inc. and Hearst SM Partnership. © 1995 - 2009 SmartMoney. All Rights Reserved.


Ginnie Mae Bonds, Student Loans, Finding a Planner (Ask SmartMoney)

QUESTION: I like the yields on GNMA bonds. What are the risks?
—Frank Summers, Santa Ana, Calif.

Anyone tracking bonds backed by “Ginnie Mae” mortgages (from the Government National Mortgage Association) is likely wondering, “What mortgage meltdown?”

Ginnie Mae creates mortgage-backed securities consisting primarily of loans guaranteed by the Federal Housing Administration, which typically backs loans to folks with shaky credit and small down payments. These bonds have had an impressive run: The Barclays Capital U.S. MBS Fixed Rate GNMA index has an 8.6 percent one-year total return, compared with 8 percent for the intermediate Treasury bond index.

Despite their government backing, Ginnie Mae bonds carry slightly more risk than Treasurys. When a mortgage is paid back early (because the homeowner has moved, refinanced or was foreclosed upon), for instance, you’ll get your money back but miss out on future interest payments. You could then buy a new GNMA bond, but if mortgage rates have fallen, you’re stuck with a lower yield. “That’s a heightened risk right now,” says Ronald Reardon, a principal in Vanguard’s fixed-income department, noting that the Obama administration wants to keep mortgage rates low. If you decide to go this route, consider a low-fee mutual fund. And beware that the recent Ginnie Mae rally may be on the verge of downsizing.

QUESTION: My son, who graduated in 2005, has ,000 in private student loans. Can he consolidate them?
—Bill Lee, Iola, Kan.

Yes, though it’s not as easy as it used to be. Private student loans can be consolidated only through private student-loan providers that specifically offer the service—and now, thanks to the credit crunch, that’s just four firms, says Mark Kantrowitz, publisher of FinAid.org, which offers a list of providers on its Web site.

Interest rates on private loans are variable and tied to another rate, like the three-month London Interbank Offering Rate (currently 0.66 percent), plus an additional 4 to 14 percent. It takes a 100-point improvement in a borrower’s credit score to garner better terms, though. Also, private loans can’t be consolidated with Federal student loans, which carry lower fixed rates.

QUESTION: How do you choose a financial planner? I don’t know where to start.
—Tania Giordani, Chicago

Start with a recommendation from someone in a similar financial situation, then tackle the due diligence. Believe it or not, anyone can call himself a financial planner or adviser, though he’ll need certain credentials for some tasks. Almost anyone offering to buy and sell securities for your account, for instance, needs to be a registered investment adviser with the Securities and Exchange Commission. Some planners work for insurance firms, which means they’re beholden to state insurance laws. Certified financial planners have met certain work requirements, passed an exam and agreed to follow the CFP Board of Standards’s ethics code.

Cost is also a consideration. Some planners charge a fee (either a flat fee or a percentage of assets), others are paid by commission, and some use a combo approach. “Obviously, if you want advice, you should expect to pay for it,” says Barbara Roper, director of investor protections for the Consumer Federation of America. “Just make sure the advice benefits you, not the salesperson.”

Finally, a preliminary meeting is usually free of charge. Ultimately, it comes down to chemistry. If it feels like a fit, you’ve found your planner.

SMARTMONEY ® Layout and look and feel of SmartMoney.com are trademarks of SmartMoney, a joint venture between Dow Jones & Company, Inc. and Hearst SM Partnership. © 1995 - 2009 SmartMoney. All Rights Reserved.


Broker Talk: Cyclical Sector Allocation Is Back (Broker Talk)

The recent market weakness might be making some investors nervous, but it also affords them an opportunity to pick up investments in cyclical sectors at more attractive prices, the brokerages say.

Who's Talking: Marc Zabicki, senior market strategist, Ameriprise Financial

The Gist: The market's "extraordinary" rally that started in early March cooled off in the last two weeks of June, but that's no cause for alarm, Zabicki says. In his view, the correction is overdue and, he says, it should be modest in nature.

"We believe the February and early March trading represented extraordinarily irrational expectations that have since been corrected by a sensible assessment of the business cycle," the strategist says. "We believe market sentiment and renewed realization of fundamentals will keep the current bout of equity weakness relatively contained."

With the market looking to be range-bound in the near term, investors would do well to take advantage of the lower stock prices and adjust their portfolios to reflect a more balanced allocation between cyclical and defensive sectors.

In fact, Zabicki upgraded early cycle sectors like industrials (to Overweight from Equal Weight) and energy (to Equal Weight from Underweight) while downgrading more defensive sectors such as consumer staples (to Equal Weight from Overweight) and utilities (to Underweight from Equal Weight).

"In our view, these shifts bring our U.S. equity allocations more balance, with no bias toward cyclical or defensive exposure," Zabicki says.

Here's how Ameriprise now weights the 10 sectors of the S&P 500:

SectorWeight
Consumer DiscretionaryUnderweight
Consumer StaplesEqual Weight
EnergyEqual Weight
FinancialsOverweight
Health CareOverweight
IndustrialsOverweight
Information TechnologyEqual Weight
MaterialsUnderweight
TelecomEqual Weight
UtilitiesUnderweight

Who's Talking: Brad Sorensen, director of market and sector analysis, Charles Schwab Center for Financial Research

The Gist: Like Zabicki, Sorensen sees the recent market weakness as an opportunity to "play the pullback" and increase exposure to more cyclical stocks at cheaper prices.

"The impressive overall market rally from the March lows has stalled, while the cyclical areas that had benefitted from hopes of an economic recovery have pulled back," says Sorensen. "However, in every situation lies an opportunity: Investors looking to make some shorter-term moves could benefit from buying stocks and funds at lower prices."

However, in contrast to Zabicki, Sorensen takes a slightly less balanced, more pro-cyclical view when it comes to sector allocation. Schwab continues to believe that global reflationary policies, combined with the possibility of a continued weakening of the dollar, will benefit the more cyclical technology, industrials and materials sectors. In contrast, they believe defensive-oriented consumer staples, telecommunication, and utilities sectors will underperform.

The differences between Ameriprise's more balanced weighting and Schwab's more aggressive outlook can be seen in their respective views of some key sectors. For example, where Ameriprise advocates overweighting financials, Schwab calls the sector at Market Perform (Ameriprise's equivalent of Equal Weight.) Schwab is also more bullish on Materials, which it puts at Outperform, vs. Ameriprise's Underweight.

Here is Schwab's recommended allocation to the 10 sectors of the S&P 500:

SectorWeight
Consumer DiscretionaryMarket Perform
Consumer StaplesUnderperform
EnergyMarket Perform
FinancialsMarket Perform
Health CareMarket Perform
IndustrialsOutperform
Information TechnologyOutperform
MaterialsOutperform
TelecomUnderperform
UtilitiesUnderperform

SMARTMONEY ® Layout and look and feel of SmartMoney.com are trademarks of SmartMoney, a joint venture between Dow Jones & Company, Inc. and Hearst SM Partnership. © 1995 - 2009 SmartMoney. All Rights Reserved.


Tempting Targets: 5 Stocks Priced for a Takeover (Screens)

Companies don't seem interested in buying rivals at the moment, despite the comparatively low prices they could pay for them. That bodes poorly for stocks in general, but investors can still use the math of takeover pros to find bargains.

U.S. shares are 27% cheaper than a year ago, even after climbing 15% in the second quarter. During the first half, though, the value of announced acquisitions in the U.S. fell 45% from a year earlier, according to data provider Dealogic. TrimTabs, an investment research group, calls the second quarter the most bearish it has seen since it started tracking data in 1995, in terms of companies' zeal for selling new shares to the public and their reluctance to spend cash to buy either their shares or entire companies.

Investors should read that as a sign of stock-market pessimism among company managers, which signals poor market returns to come, according to TrimTabs. Perhaps that makes now a good time to raise cash, or at least trade pricey stocks for cheap ones. To the latter end, I've listed five companies below that corporate suitors might think are good deals right now, if they weren't so reluctant to spend. Some of the traits that can make a company a potential takeover target can also make it a promising stock. Chief among them is a modest price.

The companies have, in the parlance of merger and acquisition pros, low EV/Ebitda ratios. EV is enterprise value, which is what an investor would pay to buy a company in its entirety and repay all of its debt. Ebitda stands for earnings before interest, taxes, depreciation and amortization. It's a measure of underlying profit potential that allows for tidy comparisons of companies. A low EV/Ebitda ratio, then, means a company had a modest takeover price relative to its earnings potential. The companies on my list also generate free cash, something acquiring firms like to see.

BJ's Wholesale Club (BJ) shares have climbed 31% over the past five years, vs. an 18% decline for the S&P 500. They now sell for 13 times forward earnings, vs. more than 16 times earnings for the index. Sales and profits for BJ's are rising at the moment, as consumers forsake full-price shops for discount clubs. The company has low profit margins relative to peers like Costco (COST), but also increasing margins, which together suggest both improvement and room for more of it.

Dell (DELL) has suffered sharp sales declines of late, but it has reduced corporate expenses and still produces impressive returns on equity, the mark of an efficient company. In the absence of a global economic recovery, the chief appeal of the stock for investors is a low price. Subtracting the company's sizable cash balance from its stock price, shares go for about 10 times forward earnings.

Listed below are details on these two companies and three others.

Screen Survivors
CompanyTickerIndustryCurr. PriceEV/EbitdaReturn on Equity (%)Dividend Yield (%)
Data as of July 1, 2009
DellDELLPersonal Computers13.735.6046.9n/a
Sherwin-WilliamsSHWChemicals53.756.8632.02.64
Eastman ChemicalEMNChemicals37.905.6314.14.64
BJ's Wholesale ClubBJDiscount Stores32.235.9914.8n/a
Weis MarketsWMKGrocery Stores33.525.938.23.46

SMARTMONEY ® Layout and look and feel of SmartMoney.com are trademarks of SmartMoney, a joint venture between Dow Jones & Company, Inc. and Hearst SM Partnership. © 1995 - 2009 SmartMoney. All Rights Reserved.


Jobs Report Slams Stocks; Dow Down 2% (Market Update)

News at a Glance

  • Labor Update: Economy lost 467k jobs in June.
  • Equities Fall: Investors disappointed by jobs report.
  • Demand Rises: Factory orders top May consensus.
  • Oil Slump: Crude prices down after inventories report.

The Lowdown

A short week on Wall Street may be coming to a bleak ending.

Stocks took an steep fall Thursday, as traders recoiled after a disappointing June employment report. Shortly before noon, each of the major indexes stood down more than 2%. The Dow Jones Industrial Average had dropped 179 points to 8325. The Nasdaq had given up 45 at 1801, and the S&P 500 had slipped 21 to 902.

All 30 of the Dow's components lost ground. Boeing (BA), Home Depot (HD) and United Technologies (UTX) were hit particularly hard.

The energy sector was also pummeled. Royal Dutch Shell (RDS.A) and ExxonMobil (XOM) each fell by more than 2% as oil prices fell on concern over demand. By 11:44 a.m., crude traded down .49 on the day at .82 a barrel.

The jobs report was a heavy weight on the broader market. Payrolls fell more than forecast in June, and the unemployment rate rose slightly, according to the Labor Department. Employers cut 467,000 jobs in June, compared to a decline of 345,000 in May. The unemployment rate hit 9.5%, up from 9.4% in May. Analysts had forecast payroll declines of 365,000 jobs and an unemployment rate of 9.6%.

World markets were broadly lower. In Europe, stocks fell Thursday after the European Central Bank held the Euro Zone's benchmark interest rate at its record low of 1%. In Asia, stocks closed down on concern that the U.S. stimulus package isn't doing enough to curb job losses.

Corporate News

  • General Motors (GM) could file for an initial public offering in 2010, said Harry Wilson, an auto task force advisor who testified in U.S. bankruptcy court Wednesday. The company was in court to get approval to sell about 60% of its assets to the Treasury. The remainder will be owned by the Canadian government and a union reitree trust fund. GM could exit bankruptcy as soon as this month.
  • Lear (LEA) plans to file for bankruptcy after reaching an agreement with secured lenders and bondholders, the company said Wednesday in a statement. The auto supplier is responding to a slowdown in sales brought on by a decline in production on the assembly lines of its major customers.
  • Exelon (EXC) raised its hostile takeover bid for NRG Energy (NRG) by 12% to .45 billion after a drop in its share price reduced the premium it had offered. The revised bid is 7.9% higher than NRG's closing price Wednesday.

The Economy

  • Payrolls fell more than expected in June, declining by 467,000, compared to a decline of 345,000 in May, according to the Labor Department. The unemployment rate is now 9.5%, up from 9.4% in May. Unemployment was expected to reach 9.6%. Hourly earnings held steady at .53 after an increase of 0.1% in May. The average workweek fell by 0.1 to 33 hours. It was expected to hold steady at 33.1 hours. REPORT
  • Weekly jobless claims fell to 614,000 in the week ending June 27, down from 627,000 the previous week, the Labor Department said. Forecasters had expected the number to come in at 615,000. REPORT
  • Factory orders rose 1.2% in May, up from a revised April increase of 0.5%, the Commerce Department said. Factory orders, which reflect demand for durable and non-durable goods, had been expected to rise 0.9%. REPORT

SMARTMONEY ® Layout and look and feel of SmartMoney.com are trademarks of SmartMoney, a joint venture between Dow Jones & Company, Inc. and Hearst SM Partnership. © 1995 - 2009 SmartMoney. All Rights Reserved.




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